Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K053599
Device Classification Name
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
More FDA Info for this Device
510(K) Number
K053599
Device Name
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH, WA 98029 US
Other 510(k) Applications for this Company
Contact
AL VAN HOUDT
Other 510(k) Applications for this Contact
Regulation Number
868.1700
More FDA Info for this Regulation Number
Classification Product Code
CBR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/2005
Decision Date
04/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact